Law Enforcement Agencies Seeking to Obtain Naloxone ... ?· Law Enforcement Agencies Seeking to Obtain…

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  • Steven W. Schierholt, Esq. John R. Kasich

    Executive Director Governor

    77 South High Street, 17th Floor, Columbus, Ohio 43215

    T: (614) 466.4143 | F: (614) 752.4836 | contact@pharmacy.ohio.gov | www.pharmacy.ohio.gov

    Law Enforcement Agencies Seeking to Obtain Naloxone Hydrochloride (Narcan)

    Updated 10-4-2016

    Per Ohio Revised Code Section 2925.61(D) a peace officer employed by a law enforcement agency is not

    subject to administrative action or criminal prosecution if the peace officer, acting in good faith, obtains

    naloxone from the peace officer's law enforcement agency and administers the naloxone to an individual

    who is apparently experiencing an opioid-related overdose.

    Per Ohio Revised Code Section 4729.51, as enacted by, a law enforcement agency is not subject to

    licensure as a terminal distributor of dangerous drugs for the sole purpose of possessing naloxone. This

    recent change permits law enforcement agencies to purchase naloxone from wholesalers or other terminal

    distributors without a license by the State of Ohio Board of Pharmacy.

    Please be advised that locations that operate correctional institutions and police dog trainers

    are still required to obtain a terminal distributor of dangerous drugs (TDDD) license. The

    agencies that have these existing TDDD licenses from the Board MAY have to submit additional

    documentation to the Board (see FAQ 3) to purchase and store naloxone.

    While you may not be required to obtain licensure to purchase naloxone, the State of Ohio Board of

    Pharmacy strongly recommends the implementation of the following safeguards to ensure the safe use of

    naloxone in the event of an opioid overdose:

    STORAGE AND TEMPERATURE CONTROL

    Naloxone should be stored at room temperature and away from light. According to the manufacturer, the

    drug must be kept out of direct light and at room temperature (between 68 and 77 degrees Fahrenheit).

    Please be aware that it should not be left in a car for extended periods of time and should not be

    subjected to extreme heat or cold (it will freeze) as it may impact the effectiveness of the medication.

    SHELF LIFE

    The shelf life of naloxone is approximately two years. All doses should be checked periodically to ensure

    that the naloxone is not adulterated. A dose of naloxone is considered adulterated when:

    a. It is beyond the manufacturers or distributors expiration date; and/or

    b. There are signs of discoloration or particulate matter in the naloxone solution.

    In order to keep track of expiration dates, law enforcement agencies should keep careful records of when

    and to whom the medication was dispensed.

    TRAINING

    The State of Ohio Board of Pharmacy strongly encourages regular trainings on the administration of

    naloxone in the event of an apparent opioid overdose. These training should consist of the following

    standard overdose response components:

    Recognizing the signs and symptoms of overdose

    Distinguishing between different types of overdose

    Performing rescue breathing

    http://www.pharmacy.ohio.gov/

  • Administering intranasal naloxone

    Follow-up care

    Such trainings can be conducted by your local EMS agency, emergency department personnel or a local

    Project DAWN (Deaths Avoided with Naloxone) staff member. A list of the local Project DAWN sites can be

    accessed here: http://www.healthy.ohio.gov/vipp/drug/ProjectDAWN.aspx

    The Attorney General has also developed an eOPOTA naloxone training video for law enforcement is

    accessible to officers via the Ohio Law Enforcement Gateway (OHLEG): https://www.ohleg.org/

    In addition, the Ohio Department of Health has a number of training resources available on its web site:

    http://www.healthy.ohio.gov/vipp/drug/ProjectDAWN.aspx

    Frequently Asked Questions

    1) What is naloxone?

    Naloxone (also known as Narcan) is a medication that can reverse an overdose that is caused by an opioid

    drug (i.e. prescription pain medication or heroin). When administered during an overdose, naloxone blocks

    the effects of opioids on the brain and restores breathing within two to eight minutes. Naloxone has been

    used safely by emergency medical professionals for more than 40 years and has only one function: to

    reverse the effects of opioids on the brain and respiratory system in order to prevent death. Naloxone has

    no potential for abuse.

    2) What type of naloxone can be administered by law enforcement in the event of a suspected

    overdose?

    There are no restrictions on the formulations of naloxone that can be used by law enforcement. The

    following are common methods of administering naloxone in the event of an overdose:

    i) Intranasal naloxone (Naloxone Nasal Spray):

    Naloxone 4mg/.1mL FDA approved nasal spray device, 2 doses per unit NDC No. 69547-353-

    02

    ii) Using a device manufactured for the intranasal administration of liquid drugs (i.e. a nasal

    spray)

    In order to administer naloxone via a nasal spray, a law enforcement agency will need to obtain the

    following:

    Luer-Jet Luer-Lock Prefilled Syringe (2 mg / 2 mL of naloxone) NDC#: 76329-3369

    http://www.healthy.ohio.gov/vipp/drug/ProjectDAWN.aspxhttps://www.ohleg.org/http://www.healthy.ohio.gov/vipp/drug/ProjectDAWN.aspx

  • MAD300 Nasal Atomization Device: This device can be ordered from a number of medical

    supply companies without a prescription (it is NOT normally stocked at a local pharmacy).

    The following provides an overview of how to assemble the nasal spray:

  • ii) Using an autoinjector in a manufactured dosage form (similar to an epi-pen)

    On April 3, 2014, the U.S. Food and Drug Administration approved the first naloxone auto injector. To

    read more about this product please visit:

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm

    Naloxone 0.4 mg/0.4 ml - NDC No. 60842-030-01

    iii) Intramuscular injection using a syringe

    Naloxone 0.4 mg/ml single dose vial, 2 vials

    NDC No. 00409-1215-01

    Syringe 3 ml 25G 1 inch No. 2

    For more information on administering naloxone intramuscularly, please visit:

    www.pharmacy.ohio.gov/naloxone and review the diagrams found in the Patient Counseling Brochure.

    3) I already have a TDDD license for my agency? What do I need to do to obtain naloxone?

    If you have an unlimited category II or category III TDDD license you are not required to do anything to

    order naloxone.

    If your agency has a limited TDDD category II or III license, you will need to update your drug list to

    reflect the addition of naloxone. The new drug list must contain the following information:

    a) the brand name (Narcan)

    b) the generic name (Naloxone)

    c) strength to be stocked (Naloxone 2 mg / 2 mL)

    d) dosage form (intranasal solution)

    You can update your drug list by visiting: http://www.pharmacy.ohio.gov/Licensing/DrugList.aspx

    BE ADVISED: Each time you revise your drug list you must upload your ENTIRE list. Previous versions

    of your drug list will not be displayed on the website; they will be replaced with your most current

    submissions once approved.

    To check to see if your agency has a terminal distributor of dangerous drugs, please visit:

    www.pharmacy.ohio.gov/licenselookup

    4) I want to order naloxone for my agency, where do I purchase it?

    Naloxone can be obtained by three methods.

    Wholesale Purchase: A law enforcement agency is permitted to order the drug from a wholesaler that

    is licensed by the State of Ohio Board of Pharmacy. To verify a wholesale drug distributor is licensed in

    Ohio, visit: www.pharmacy.ohio.gov/licenselookup

    Wholesale Purchase from a Pharmacy: The State of Ohio Board of Pharmacy permits a pharmacy

    licensed as a terminal distributor dangerous drugs to conduct an occasional sale of drugs at wholesale.

    There are no restrictions on the amount that can be provided by a pharmacy to a law

    enforcement agency pursuant to rule 4729-9-10.

    The Ohio Department of Mental Health and Addiction Services operates Ohio Pharmacy Services, which

    sells naloxone kits to local governments, including law enforcement. To contact Ohio Pharmacy Services,

    please call: 614-752-0158.

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htmhttp://www.pharmacy.ohio.gov/naloxonehttp://www.pharmacy.ohio.gov/Licensing/DrugList.aspxhttp://www.pharmacy.ohio.gov/licenselookuphttp://www.pharmacy.ohio.gov/licenselookuphttp://codes.ohio.gov/oac/4729-9-10

  • Wholesale Purchase from a Local Health Department: The State of Ohio Board of Pharmacy also

    permits a health department licensed as a terminal distributor dangerous drugs to provide naloxone at

    wholesale to a law enforcement agency. Please be advised that the terminal distributor must properly

    document the transaction (even if the health department is donating the naloxone). There are no

    restrictions on the amount that can be provided by a health department to a law enforcement

    agency.

    The State of Ohio Board of Pharmacy strongly supports efforts to reduce opioid overdose death through

    expanded use of naloxone. If you have any questions regarding the purchase, storage or use of naloxone,

    please call us at 614-466-4143 or email us by visiting http://www.pharmacy.ohio.gov/Contact.aspx and

    we will do everything we can to assist you.

    5) Is there any financial assistance available for paying for the medication?

    On March 2, 2015, Ohio Attorney General Mike DeWine and Amphastar Pharmaceuticals, Inc. entered into

    an agreement where the drug manufacturer has agreed to provide a $6 rebate for each Amphastar

    naloxone syringe purchased by certain Ohio public entities for the next year. A copy of that agreement can

    be found at

    www.OhioAttorneyGeneral.gov/AmphastarRebateAgreement. As part of the agreement, the Ohio Attorney

    General has agreed to process all of the rebate requests. For more information about the rebate, please

    visit: http://www.ohioattorneygeneral.gov/naloxonerebate

    The Ohio Mental Health and Addiction Services (OhioMHAS) is committing up to $500,000 in each state

    fiscal year to enhance access to naloxone in every Ohio county. Funds allocated to the department will be

    used to purchase naloxone, including complete Project DAWN Kits (Death Avoidance With Naloxone), for

    distribution to county health departments to dispense to local law enforcement, emergency personnel and

    first responders (as required by House Bill 64). For more information, please visit:

    http://mha.ohio.gov/Default.aspx?tabid=817

    http://www.pharmacy.ohio.gov/Contact.aspxhttp://www.ohioattorneygeneral.gov/AmphastarRebateAgreementhttp://www.ohioattorneygeneral.gov/naloxonerebatehttp://mha.ohio.gov/Default.aspx?tabid=817

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